Hemostatic device

This application is a continuation of International Application No. PCT/JP2022/020040 filed on May 12, 2022, which claims priority to Japanese Application No. 2021-082265 filed on May 14, 2021, the entire content of both of which is incorporated herein by reference.

The present disclosure generally relates to a hemostatic device.

As one of catheter procedures, a procedure is known in which various elongated medical devices are introduced into a blood vessel through a puncture site formed by puncturing the blood vessel of an arm or hand of a patient, and treatment or cure is performed on a lesion site.

For example, International Patent Application Publication No. WO2019/090104A discloses a hemostatic device for stopping bleeding at a puncture site formed to enable access to a blood vessel (including a distal radial artery) running in a hand.

The hemostatic device disclosed in International Patent Application Publication No. WO2019/090104 includes: an inflatable member that applies a compressive force to a puncture site formed in a hand of a patient; a fixing member that fixes a pressing member to the hand of the patient; an injection member including a port (connector portion) that can inject a fluid for inflating the inflatable member, and a tube portion that connects the connector portion to an inner cavity of the inflatable member; and a tube fixing portion that is located on the fixing member and can fix the tube portion.

An operator such as a doctor (hereinafter, referred to as an “operator”) can help prevent the inflatable member from shifting from the puncture site formed in the hand of the patient by fixing the hemostatic device using bands in a state in which the inflatable member is disposed at the puncture site formed in the hand of the patient and a peripheral site of puncture site when stopping bleeding at the puncture site formed in the hand of the patient using the hemostatic device disclosed in International Patent Application Publication No. WO2019/090104.

The operator can reduce movement of the tube portion following movement of the hand of the patient by fixing the tube portion to the tube fixing portion.

However, the hemostatic device disclosed in International Patent Application Publication No. WO2019/090104 may have the following problems.

In the hemostatic device disclosed in International Patent Application Publication No. WO2019/090104, a groove for fixing the tube portion is formed in the tube fixing portion.

Therefore, when the operator attaches the tube portion to and detaches the tube portion from the tube fixing portion, the operator needs to deform (for example, elastically deform) the tube fixing portion in a direction in which the groove is widened by an external force applied to the tube portion.

At this time, the force required for the operator to deform the tube fixing portion in the direction in which the groove is widened is determined by a mechanical configuration of the tube fixing portion, but the configuration may not be designed in consideration of operability and convenience of the operator.

For example, when a force required for the operator to attach the tube portion to and detach the tube portion from the tube fixing portion is relatively large, the external force (the force applied by the operator) is transmitted to the inflatable member via the fixing member provided with the tube fixing portion, and thus the external force may be unintentionally applied to the puncture site.

When the external force is transmitted to the fixing member, the external force can be unintentionally transmitted to the inflatable member, and the inflatable member may shift from the puncture site formed in the hand of the patient accordingly.

The present disclosure helps prevent an external force from being unintentionally applied to a puncture site due to transmission of the external force applied to a tube portion by an operator to an inflatable member via a tube fixing portion and a fixing member when the operator attaches the tube portion to and detaches the tube portion from the tube fixing portion in a state in which a hemostatic device is attached to a hand of a patient, and/or to help prevent the hemostatic device from shifting due to unintentional application of an external force to the inflatable member caused by transmission of the external force applied to the tube portion by the operator to the fixing member via the tube fixing portion.

A hemostatic device according to the disclosure includes: an inflatable member configured to compress a site where bleeding is to be stopped in a limb of a patient; a fixing member configured to secure or fix the inflatable member to the limb of the patient; an injection member including a connector portion configured to inject a fluid for inflating the inflatable member, and a tube portion connecting the connector portion to an inner cavity of the inflatable member; and a tube fixing portion located on the fixing member and configured to secure or fix the tube portion. The tube fixing portion includes a first member, a second member located closer to the inflatable member than is the first member and facing the first member, a slit portion formed between the first member and the second member and configured to allow insertion of the tube portion, and a tube holding portion surrounded by the first member, the second member, and the slit portion and configured to hold the tube portion. The first member includes a first portion, a first curved portion curved toward the second member, and a first distal-end surface located at a distal end of the first curved portion. The second member includes a second portion, a second curved portion curved toward the first member, and a second distal-end surface located at a distal end of the second curved portion and facing the first distal-end surface across the slit portion. A part of the first member is further away from the inflatable member than is the second member in a direction perpendicular to a virtual plane defined by the slit portion. The first distal-end surface includes a first region not facing the second distal-end surface across the slit portion and a second region facing the second distal-end surface across the slit portion. The first curved portion has a first curved surface curved toward the second member. The first curved surface faces the second distal-end surface across the tube holding portion.

In the hemostatic device configured as described above, by providing a height difference between the first member and the second member forming the tube fixing portion, a region where a distal-end surface (first distal-end surface) of the first member and a distal-end surface (second distal-end surface) of the second member face each other across the slit portion is reduced.

Therefore, when an operator pushes the tube portion into the tube fixing portion (inserts into the tube fixing portion), the first member is deformed in a direction in which the slit portion is widened, and then the second member is deformed.

Accordingly, the hemostatic device can reduce a force required for the operator to insert the tube portion into the tube fixing portion in a state of being attached to a hand of the patient.

The first member of the hemostatic device includes a first curved surface at a position facing the second distal-end surface of the second member across the tube holding portion.

Therefore, when the operator separates the tube portion from the tube fixing portion (removes from the tube fixing portion), the tube portion is moved from the tube holding portion toward the slit portion with the first curved surface as a guide surface.

Accordingly, the hemostatic device can reduce a force required for the operator to remove the tube portion from the tube fixing portion.

A tube fixing portion that is provided on a fixing member configured to fix an inflatable member of a hemostatic device to a patient is disclosed, the tube fixing portion includes: a first member, a second member located closer to the inflatable member than the first member and facing the first member; a slit portion formed between the first member and the second member and configured to allow insertion of a tube portion configured to be connected to an inner cavity of the inflatable member; a tube holding portion surrounded by the first member, the second member, and the slit portion and configured to hold the tube portion; the first member includes a first portion, a first curved portion curved toward the second member, and a first distal-end surface located at a distal end of the first curved portion; and the second member includes a second portion, a second curved portion curved toward the first member, and a second distal-end surface located at a distal end of the second curved portion and facing the first distal-end surface across the slit portion.

A method is disclosed for attaching a hemostatic device to a site where bleeding is to be stopped in a limb of a patient, the method includes: positioning an inflatable member fixed on a support member of the hemostatic device over the site to where the bleeding is to be stopped in the limb of the patient; securing the inflatable member of the hemostatic device to the limb of the patient with a plurality of bands connected to the support member; and fixing a tube portion of an injection member to the support member using a tube fixing portion located on the support member and configured to fix the tube portion, the tube fixing portion including a first member, a second member located closer to the inflatable member than is the first member and facing the first member, a slit portion formed between the first member and the second member and configured to allow insertion of the tube portion, and a tube holding portion surrounded by the first member, the second member, and the slit portion and configured to hold the tube portion.

As described above, since the hemostatic device can reduce a force required for the operator to attach the tube portion to and detach the tube portion from the tube fixing portion in a state of being attached to the hand of the patient, it is possible to prevent an external force from being unintentionally applied to the puncture site and/or to prevent the hemostatic device from shifting due to unintentional application of an external force to the inflatable member.

Set forth below with reference to the accompanying drawings is a detailed description of embodiments of a hemostatic device.

The following description does not limit the technical scope and meaning of terms described in the claims.

Dimensional ratios in the drawings are exaggerated for convenience of illustration, and may be different from actual ratios.

are views showing a hemostatic deviceaccording to the present embodiment, andare views showing a usage example of the hemostatic device.

For example, as shown in, the hemostatic devicecan be used to stop bleeding at a puncture site (for example, each of puncture sites pand pto be described later) formed in a hand H located on a distal side (finger side) with respect to a forearm A of a patient when a sheath tube of an introducerthat is indwelled in the puncture site is removed.

A specific position of the puncture site where bleeding is to be stopped by the hemostatic deviceis not particularly limited, and the following first puncture site pis exemplified in the present embodiment.

As shown in, the first puncture site pis a puncture site formed in an artery B (hereinafter also referred to as a “blood vessel B”) located in a snuff box of a palmar artery running on a dorsal side Hb of a right hand H(hand H) located on a distal side with respect to the forearm A of the patient.

The snuff box is a hollow of the hand located near a radius when the patient spreads a thumb of the hand H.

As shown in, the second puncture site pis a puncture site formed in a distal radial artery located on a distal side with respect to the snuff box of the palmar artery running on the dorsal side Hb of the right hand Hof the patient. The second puncture site pis located on a distal side of the right hand Hwith respect to the first puncture site pwith reference to an extensor pollicis longus tendon t located at the dorsal side Hb of the right hand Hof the patient.

Hereinafter, the hemostatic devicewill be described.

Hemostatic Device

As shown inand, the hemostatic devicecan include: an inflatable memberthat compresses the first puncture site pformed on the right hand Hof the patient; a fixing memberthat can fix the inflatable memberto the right hand Hof the patient; an injection memberincluding a connector portionthat can inject a fluid for inflating the inflatable member, and a tube portionthat connects the connector portionto an inner cavityof the inflatable member; and a tube fixing portionthat is located on the fixing memberand is configured to be capable of fixing the tube portion.

Inflatable Member

As shown in, the inflatable membercan be implemented, for example, by a single balloon having the inner cavitypartitioned by a film member.

The inflatable membercan be formed by, for example, joining edge portions of two sheet-shaped film members formed in a substantially rectangular shape in a state in which the inner cavityis defined between the two sheet-shaped film members.

The inflatable membermay be formed of, for example, a single film-shaped member formed in a bag shape so as to have an inner cavity.

The inflatable memberis inflated when a fluid such as air is supplied to the inner cavity, and is contracted when the fluid supplied to the inner cavityis discharged.

show cross-sectional views when the fluid is supplied to the inflatable memberand the inflatable memberis inflated.

The film member forming the inflatable membercan be made of, for example, a resin material having a predetermined thickness. The tube portion(see) to be described later is connected to the inner cavityof the inflatable member.

A material of the film member forming the inflatable memberis not particularly limited, and examples of the material of the film member forming the inflatable membercan include polyolefins such as polyvinyl chloride, polyethylene, polypropylene, polybutadiene, and ethylene-vinyl acetate copolymer (EVA), polyesters such as polyethylene terephthalate (PET) and polybutylene terephthalate (PBT), various thermoplastic elastomers such as polyvinylidene chloride, silicone, polyurethane, polyamide elastomer, polyurethane elastomer, and polyester elastomer, nylon, nylon elastomer, and any combination thereof (blend resin, polymer alloy, laminate, and the like).

As shown in, the inflatable memberis disposed on an inner surfaceside of a support memberprovided on the fixing member.

An inner surfaceof the support memberis a surface disposed on a surface side of the hand H of the patient when the hemostatic deviceis attached to the hand H of the patient. An outer surfaceof the support memberis a surface opposite to the inner surface

The inflatable membercan be directly connected to the inner surfaceof the support member. The inflatable memberand the support membercan be connected by, for example, fusion bonding or adhesion.

The inflatable membermay be connected to the inner surfaceof the support membervia another member.

The inflatable membermay be, for example, formed of a single film-shaped member defining an inner cavity between the inflatable memberand the inner surfaceof the support member. For example, the inflatable membermay be configured such that one film-shaped member is directly connected to the inner surfaceof the support member, and an inner cavity is defined between the inner surfaceof the support memberand the one film-shaped member.

The inflatable memberhas a circular shape in a plan view shown in.